Health IT Expertise Helping to Achieve Your Mission

Health Analyses, Studies and Research

Support disease management systems such as the CDC ALS Registry Portal, and enable the integration of health systems such as FDA’s Laboratory Information Management Systems (LIMS) which automates national laboratory data collection and enables lab interoperability.

Information and Knowledge Management

Implemented the FDA Center for Drug Evaluation and Research (CDER) Data Standards Governance framework to resolve current data challenges in the areas of data standards governance and data standardization.

Helped CDC develop the Environmental Burden Index (EBI) to support environmental public health research and presented at the American Public Health Association (APHA) November 2015 Annual Meeting.

Conducted planning and analysis of on-premise and cloud-based IT security requirements for FDA CDRH business systems.

Conduct IT Security Planning and Analysis of On-Premise and Cloud IT Security Requirements for FDA CDRH business systems.

Use Geospatial Information Systems (GIS) modeling to help eradicate polio, study disease transfer, and respond to national and global health emergencies such as the Ebola and Zika virus epidemics.

Helped develop the Environmental Burden Index (EBI), the first nationwide estimate of environmental quality available at the census tract level.

Included a global unique identifier to anonymize ALS patient data for privacy, improving the quality and completeness of CDC research data.

Health IT Strategy and Solutions Planning

Led concept design for the Real-time Application for Portable Interactive Devices (RAPID), stemming from the H1N1 crisis that highlighted the need for improved communication for EUA-related adverse event reporting between health practitioners and the FDA.

Conducted an impact analysis for the implementation of the Individual Case Study Reports (ICSR) R3 standards for adverse event reporting. The analysis provided insights into how data structure changes could be better used by FDA safety reviewers and epidemiologists.

Collaborated with the FDA to develop a high-level IT Strategy “Roadmap” and implementation plan aligned to the Food Safety Modernization Act (FSMA) objectives to use technology to prevent food contamination.

DRT support for FDA’s Regulatory Review Training program included redesign and enhancement of training curriculum to provide a hands-on “real world” experience for trainees, added depth and breadth of content, and diversified delivery mechanisms including computer-based training.